Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of 610 in patients with severe asthma

Conditions: Asthma

Summary: the primary objective of the study is to evaluate the efficacy and safety of 610 in chinese adults with severe asthma.

the total duration of study per patient is approximately 66 weeks, including 6 weeks of screening period, 52 weeks of treatment period and 8 weeks of follow-up period.

Eligibility criteria:
inclusion criteria: 1. able to give written informed consent prior to participation in the study. 2. male or female adults ages 18 to 75 years old when signing the informed consent. 3. documented diagnosis of asthma for at least one year prior to screening. 4. history of physician-diagnosed asthma requiring treatment with ics and at least one other control medication for at least 6 months prior to screening. exclusion criteria: 1. presence of a known pre-existing, clinically important lung condition other than asthma. 2. severe asthma exacerbation within 4 weeks prior to randomization. 3. subjects with any eosinophilic diseases other than asthma. 4. known, pre-existing severe or clinically significant cardiovascular disease. 5. known, pre-existing other concurrent clinically significant medical conditions that are uncontrolled with standard treatment. 6. subjects who have active hepatitis b, hepatitis c or hiv infections as determined by positive results at screening. 7. subjects with allergy/intolerance to a monoclonal antibody.
frequency of piriformis syndrome:does the presence of one pathology rule out the other?

Conditions: Chronic Pain

Summary: the purpose of the investigators is to determine the frequency of priformis syndrome in patients presenting with hip and/or leg pain and to investigate the association of priformis syndrome with other pathologies of the lumbar spine and hip.

priformis syndrome is a neuromuscular disorder characterized by compression or irritation of the sciatic nerve under the piriformis muscle, tenderness in the piriformis muscle, and back, hip, and leg pain. the pain may radiate along the sciatic nerve trace in the gluteal region and posterior thigh. diagnosis is based on clinical symptoms, specific physical examination findings, and positive response to local injection. the diagnosis of piriformis syndrome is usually made only after lumbar spine pathologies are excluded. this traditional approach leads to underdiagnosis of piriformis syndrome. more than one cause may coexist in hip and/or leg pain.the existence of one cause does not exclude the other.priformis syndrome should not be a diagnosis of exclusion. in the differential diagnosis of hip and/or leg pain, physical examination to exclude piriformis syndrome and injection of local anesthetic into the piriformis muscle is much less invasive than surgery to confirm lumbar spine pathology and can be performed as an outpatient.thus, early diagnosis and appropriate treatment process is accelerated. if there is an unfavorable response to the local injection, investigation for lumbar vertebral pathologies can be initiated. the purpose of the investigators under this information and justifications is; to determine the frequency of priformis syndrome in patients presenting with hip and/or leg pain and to investigate the association of priformis syndrome with other pathologies of the lumbar spine and hip.

Eligibility criteria:
inclusion criteria: * patients presenting with unilateral hip and/or leg pain exclusion criteria: * no

Keywords: piriformis syndrome myofascial pain ultrasound guidance trigger point injection
haploidentical stem cell transplantation in neuroblastoma

Conditions: Neuroblastoma

Summary: children with primary resistant or relapsed neuroblastoma who do not achieve remission with conventional chemotherapy have extremely dismal prognosis. a novel treatment strategy combining tumor targeted radioisotope treatment with metaiodobenzylguanidine (mibg) and immunotherapeutic effect of haploidentical stem cell transplantation (haplosct) followed by low-dose donor lymphocyte infusions will be piloted. the use of the isotope is aimed to decrease pre-transplant tumour burden. reduced intensity conditioning containing fludarabine, thiotepa and melfalan will enable sustained engraftment as well as will serve as additional anti-tumor treatment. a prompt natural killer (nk)-cell mediated tumour control may be achieved by haploidentical stem cell transplantation. the investigators hypothesize that tumour cells potentially evading nk-cell mediated immunity may be targeted by infused donor t-cells and eliminated by either mhc-dependent manner or through a bystander effect. the possible graft versus tumor effect will be evaluated in children with therapy resistant neuroblastoma.


Eligibility criteria:
inclusion criteria: * refractory neuroblastoma (any chemo/radiosensitive stable disease) * relapse incl. autologous hsct 3 m earlier * primary induction failure * cardiac output sf ≥25% * creatinine clearance ≥40 cc/min/1.73 m2 * performance score of ≥50% (lansky or karnofsky) * available haploidentical family donor, aged ≥18 yrs, hiv-neg exclusion criteria: * rapidly progressive disease * pregnancy

Keywords: radiotherapy immunotherapy hematopoietic stem cell transplantation
predictive and prognostic value of inflammatory markers and microrna in stage iv colorectal cancer

Conditions: Colorectal Cancer Stage IV

Summary: this study investigates the predictive and prognostic values of inflammatory markers and microrna in stage iv colorectal cancer. the expression of inflammatory markers and microrna in plasma will be correlated with tumor location, with dietary patterns and with survival during treatment.

colorectal cancer (crc) is responsible for 10% of the world-wide cancer incidence and mortality. recent data have shown that tumors arising from different regions of the colon differ in their molecular characteristics which causes translate into a differential clinical outcome.several studies described the role of microrna expression in the initiation and progression of crc and its response to different therapeutic strategies. other studies have shown that systemic inflammation is a key determinant role of clinico-pathological outcomes in patients with crc. we therefore aim to evaluate the expression of selected microrna and inflammatory markers in patients with stage iv colorectal cancer and assess their correlation with tumor location, dietary patterns, survival rates, response to systemic chemotherapy and other clinic-pathological parameters. we believe that identifying a predictive and prognostic panel made up of circulating microrna and inflammatory markers may perhaps explain the difference in outcome between right and left colon and perhaps impact the clinical practice in patients with stage iv colorectal cancer.

Eligibility criteria:
inclusion criteria: 1. newly diagnosed stage iv colorectal cancer 2. treatment naïve 3. for the control group: adult individuals (above 18 years) with no cancer disease exclusion criteria: any disease or condition that may alter the inflammatory and immune status of subjects at baseline, such as: 1. diagnosis of inflammatory bowel disease such as ulcerative colitis and crohn's disease. 2. diagnosis of active systemic autoimmune disease 3. chronic / recent use of corticosteroids 4. use of immunosuppressant drugs

Keywords: biomarker colorectal cancer prognosis prediction microrna inflammation dietary pattern
a study to look at antiepileptic drug levels while on lamictal or depakote with or without an oral contraceptive

Conditions: Epilepsy

Summary: some antiseizure medication levels are affected by hormones. this study is being done to determine if blood levels of lamotrigine or valproate are affected by the hormones in the birth control pill or the menstrual cycle itself.

participants will be given informed consent and will be asked to have two blood draws at specific times of the menstrual cycle or if on a birth control pill, during the active and inactive pill phases.

Eligibility criteria:
inclusion criteria: * must be a female between 13-45 years of age * must have a history of seizures * must be taking either lamotrigine (lamictal) or valproate (depakote) with or without a birth control pill exclusion criteria: * must not be on antidepressant medication, tranquilizers, or other forms of hormonal therapy other than the birth control pill

Keywords: epilepsy menstrual cycle valproate lamotrigine oral contraceptive
a study of safety and effectiveness of novothirteen® (rfxiii) during treatment of congenital fxiii deficiency in japan

Conditions: Congenital Bleeding Disorder; Congenital FXIII Deficiency

Summary: this study is conducted in asia. tha aim of this study is to investigate safety and effectiveness of novothirteen® (rfxiii) during treatment of congenital fxiii deficiency in japan.


Eligibility criteria:
inclusion criteria: * male of female patients, regardless of age, requiring treatment with novothirteenr for whom the treating physician has decided to use novothirteenr (rfxiii) treatment
single dose and multiple dose safety, tolerability, pk，and food effect study，and interaction with oseltamivir study of hec116094 in healthy adult subjects

Conditions: Influenza

Summary: the safety, tolerability, pharmacokinetic, food effect study and the interaction with oseltamivir phosphate capsules of hec116094 in healthy subjects


Eligibility criteria:
inclusion criteria: * willing to participate in the study, able to understand and sign the informed consent, and able to complete the the study in accordance with the requirements of the study. * female subjects who are not pregnant or lactating and male subjects whose female partners are fertile shall voluntarily take effective contraceptive measures from the date of signing the informed consent form to 3 months after the medication. * when signing the informed consent, 18 years old ≤the age≤45 years old(including the critical value), gender is not limited. * male body weight ≥50kg, female body weight ≥45kg, and body mass index (bmi) in the range of 18-28 kg/m2 (including the critical value). * no clinical significance of vital signs, physical examination, laboratory examination, electrocardiogram, ultrasound abdomen and chest x-ray (posterior and anterior) results. exclusion criteria: * positive for viral hepatitis (including hepatitis b and c), hiv and syphilis. * those who are known to have allergy history or allergy constitution to the test preparation and any of its components or related preparations. * consume foods or beverages containing caffeine, xanthine, alcohol, and grapefruit within 48 hours prior to initial dosing. * positive results from urine drug screen test. * donate blood or lose blood 400 ml or more within 1 month prior to initial dosing. * subjects who plan to receive or have had organ transplants. * subjects considered by the investigator to have other factors unsuitable for participation in this study.
human breast milk's role in food allergy development

Conditions: Food Allergy in Infants; Food Allergen Sensitisation; Breast Feeding, Exclusive; Breastmilk Collection

Summary: the goal of this prospective cohort pilot study is to learn about food allergens being passed on in breast milk to breast feeding infants. the main question\[s\] it aims to answer are: * will major allergens for milk, egg, and peanut be passed on to infants in breast milk? * will the infants become sensitized to and develop an allergy to the food allergens found in breast milk? * will early introduction interventions prevent the development of these food allergies? participants will * provide breast milk sample (s) for testing for food allergens * infants will be tested for sensitization via skin prick and blood testing * infants will be challenge with suspected foods to determine allergy and undergo early introduction procedures

recruitment of subjects will be open enrollment pregnant or post-partum women with a personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, atopic dermatitis (eczema), and/or food allergy who are exclusively breastfeeding. mothers will provide a breastmilk sample(s) for testing of allergens to milk, egg, and wheat. prior to the introduction of solid foods, infants will need to be tested for sensitization to milk, egg, and wheat via skin prick testing and blood allergy testing. infants that are negative for sensitization will undergo introduction of these foods per standard practice. infants that are positive for sensitization will undergo an office food challenge for those foods that they are sensitized to. a positive food challenge is diagnostic for a food allergy and they will be managed according to standard practice. a negative food challenge means that they are not allergic, and they will undergo early introduction protocols and monitored to continued tolerance.

Eligibility criteria:
inclusion criteria: 1. pregnant or post-partum females who plan to exclusively breastfeed and their infants who have completed at least 37 weeks of gestation 1. these are vulnerable populations 2. our study involves breastmilk analysis, which we need postpartum mothers to supply. 3. (parent) testing will be done solely on breastmilk samples, with only potential dietary intervention done to the parent postpartum depending on the outcomes of the infant and breastmilk. 4. (infant) in order to determine if allergens in breastmilk play a role in food allergen sensitization, we need to test the infants prior to the introduction of solid foods. 2. personal history of atopic disease such as allergic rhinitis/conjunctivitis, asthma, food allergies, and atopic dermatitis 3. maternal diet must include hen's egg, cow's milk, and wheat products. exclusion criteria: 1. no maternal history of atopic disease 2. exclusive formula feeding 3. maternal diet devoid of hen's egg, cow's milk, or wheat, for example, vegan diets and persons with gluten sensitivity.

Keywords: food allergy breastmilk allergen testing food allergen sensitization cow milk allergy egg allergy wheat allergy
investigation of the serotoninergic system in multiple system atrophy: a positron emission tomography (pet) study

Conditions: Multiple System Atrophy

Summary: multiple system atrophy (msa) is a sporadic neurodegenerative disorder of the adult associated to a poor prognosis. msa is clinically characterized by the association of extra-pyramidal, dysautonomic, cerebellar and pyramidal symptoms. histological and biological studies have raised the hypothesis that, beside the well known dopamine deficiency, some of the symptoms could be related to a dysfunction in serotoninergic neurotransmission. serotonin is involved in the modulation of several functions impaired in msa, such as mood, motricity or sleep. the recent description of an association between loss of brainstem serotonin neurons and sudden death in patients with msa reinforced the hypothesis of a critical role played by this neurotransmitter in the pathophysiology of this disease. autoreceptors called 5-ht1a are strongly involved in the regulation of serotonin neurotransmission. during the last years several radio-ligands allowing in vivo pet quantification of 5-ht1a receptors, such as 18f-mppf (4-(2'-methoxyphenyl)-1-\[2'-(n-2''-piridinyl)-p-fluorobenzamide\]methylpiperazine), were developed. moreover, the investigators recently demonstrated the ability of this brain functional imaging method to investigate, in healthy volunteers, the functional properties of 5-ht1a autoreceptors through an evaluation of their desensitization after a single oral dose of fluoxetine.


Eligibility criteria:
inclusion criteria: * patients with multiple system atrophy (msa) * msa possible or probable * male and female * age : 30 to 80 * no cognitive impairment * unmodified treatment for 2 months * able to give informed consent * affiliated to social insurance * patients with idiopathic parkinson's disease (ipd): * positive clinical criteria for ipd * male and female * age : 30 to 80 * no cognitive impairment * unmodified treatment for 2 months * able to give informed consent * affiliated to social insurance * healthy controls: * absence of neuropsychiatric disorder * male and female * age : 30 to 80 * able to give informed consent * affiliated to social insurance exclusion criteria: * patients with multiple system atrophy (msa) * other parkinsonian syndrome * dementia * recent intake (\< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-ht1a receptors * history of major depression * contraindication to brain mri * contraindication to pet * patients with idiopathic parkinson's disease * other parkinsonian syndrome * dementia * recent intake (\< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-ht1a receptors * history of major depression * contraindication to brain mri * contraindication to pet * healthy controls: * patient having a neuropsychiatric disease * recent intake (\< 4 weeks or 8 weeks for fluoxetine) of medication acting on 5-ht1a receptors * history of major depression * contraindication to brain mri * contraindication to pet
a study of allogeneic mesenchymal bone marrow cells in subjects with ischemic stroke

Conditions: Ischemic Stroke

Summary: the purpose of this study is to assess the safety and tolerability of allogeneic adult mesenchymal bone marrow cells administered intravenously to patients with ischemic stroke.

stroke remains a major global healthcare problem. recent data compiled by the american heart association (aha) for 2008 show that the annual incidence of new or recurrent stroke in the united states is about 780,000, with approximately 600,000 of these strokes being first attacks. among adults age 20 and older, the estimated prevalence of stroke in 2005 was 5.8 million in the united states, resulting in \>150,000 deaths annually, with 4.8 million stroke survivors alive today. stroke ranks as the country's third leading cause of death, behind only cancer and heart disease. the only approved treatments of acute ischemic stroke involve restoring blood flow to the affected region by using thrombolytics or mechanical devices that physically remove clots. however, the use of thrombolytics is limited due to the therapeutic window of \< 3-6 hours post onset of stroke symptoms such that only a small fraction of stroke patients receive this therapy. following the completion of a stroke, there is little therapy to offer patients to promote recovery other than physical, occupational, and speech therapy. allogeneic mesenchymal stem cells have been used in a number of clinical trials for different indications demonstrated the safety of allogeneic mesenchymal stem cell treatment. in addition to their ability to differentiate into multiple different cell types that would be contributory to the recovery and repair of the brain by replacing destroyed cells, mesenchymal stem cells also secrete angiogenins, cytokines and trophic factors that can support and stimulate multiple other cell types. the cascade of cellular events following the release of these cytokines and trophic factors would also potentially lead to beneficial effects by restoring blood supply, by rescuing cells at risk, and by stimulating the remaining cell populations to repair and propagate new cells and synaptic connections.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of ischemic stroke for longer than 6 months * brain ct/mri scan at initial diagnosis and at enrollment consistent with ischemic stroke * no substantial improvement in neurologic or functional deficits for the 2 months prior to enrollment * nihss score between 6-20 * life expectancy greater than 12 months * prior to treatment patient received standard medical care for the secondary prevention of ischemic stroke * adequate organ function as defined by the following criteria: exclusion criteria: * history of uncontrolled seizure disorder * history of cancer within the past 5 years. * history of cerebral neoplasm * positive for hepatitis b, c or hiv * myocardial infarction withing six months of study entry * findings on baseline ct suggestive of subarachnoid or intracerebral hemorrhage within past 12 months. * allergies to bovine or porcine products

Keywords: allogeneic adult stem cells stroke ischemic
4d- flow- mri after aortic valve surgery

Conditions: Aortic Valve Disease

Summary: this randomized controlled trial was designed to analyze flow patterns in the ascending aorta with mri after either trileaflet reconstruction of the aortic valve with autologous pericardium (trirec) or surgical valve replacement with biological prosthesis. the hypothesis is that after trirec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis.

trileaflet reconstruction of the aortic valve with autologous pericardium (trirec) is a new treatment option for diseased aortic valves and offers benefits compared to conventional valve replacement. at the moment no prospective randomized trials evaluating the role of the trirec procedure are available and factors contributing to long- term durability are unknown. the investigators want to examine aortic flow patterns with 4d- flow- magnetic resonance imaging (mri) in patients after the trirec procedure or biological prosthetic valve replacement in a prospective randomized trial. flow patterns in the ascending aorta, examined with 4d- flow- mri, show nearly laminar flow patterns and no outflow obstruction in healthy subjects with tricuspid aortic valves. in contrast, helical flow patterns, turbulences and increased flow velocities are observed in diseased valves and also after valve replacement with mechanical or biological prostheses. these helical flow patterns seem to influence aortic wall remodeling and may contribute to structural valve dysfunction of biological prosthesis. the investigators hypothesize that after trirec procedure more physiological flow patterns will be observed, compared to biological valve prosthesis. the results can contribute to understand mechanisms for long- term performance of this technique and determine the role of this novel technique for treatment of aortic valve disease.

Eligibility criteria:
inclusion criteria: * age \> 50 years * documented symptomatic moderate or greater aortic stenosis or severe aortic insufficiency * aortic annulus \> 19 mm * written informed consent of the patients. exclusion criteria: * concomitant intervention of the aortic root, ascending aorta or aortic arch * concomitant valve surgery * emergency surgery for any reason * neurological events (i.e. stroke, tia) within the previous 6 months * coagulation disorders (including thrombocytopenia \< 100.000/ml) * porcelain aorta/severe calcification of the ascending aorta * active endocarditis or other active systemic infections * participating in another trial that may influence the outcome of this trial * pregnancy * dual antiplatelet therapy * previous cardiac surgery (excluding percutaneous procedures) * contraindication for mri- examinations

Keywords: aortic stenosis aortic regurgitation trileaflet reconstruction of the aortic valve biological aortic valve prosthesis aortic flow patterns mri